Occluder devices

ABSTRACT

Various aspects of the present disclosure are directed toward systems, methods, and apparatuses that include an occlusion device having a barrier member. The barrier member may include an enlargeable portion and a tail portion extending from the enlargeable portion. The enlargeable portion and the tail portion are releasably coupled to the delivery catheter such that the tail portion is radially unsupported and collapsible upon deployment.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Application No.62/668,505, filed May 8, 2018, which is incorporated herein by referencein its entirety for all purposes.

FIELD

The present disclosure relates generally to implantable medical devices,and more specifically to implantable medical devices for occluding,inhibiting, or preventing material movement and/or fluid flow throughtissue apertures or body lumens.

BACKGROUND

Endovascular embolization is a treatment for various diseases andconditions in which blood vessels or other vascular channels and bodylumens are malformed, distended, and/or ruptured. Examples of suchconditions include aneurysms, arteriovenous malformations, and certainoncological conditions, among others. Embolization can involve occludingor blocking the malformed regions or passageways to prevent blood flowto certain areas of the body such as, for example, a tumor or ananeurysm. In some examples, a certain vessel or passageway may beoccluded to force and/or increase fluid flow through an adjacent vessel.

A number of occluding devices exist for the treatment of suchconditions, some of which include coils, balloons, foam, plugs, andothers. Such devices generally cut off blood supply to the affectedarea.

SUMMARY

Various examples relate to implantable medical devices and systems foroccluding, inhibiting, or preventing material movement and/or fluid flowthrough tissue apertures or body lumens. In particular, various examplesrelate to an occlusion device or system including a barrier memberhaving an enlargeable portion, an anchor feature, and a collapsible tailportion.

According to one example (“Example 1”), an occlusion system includes adelivery catheter. The delivery catheter has a proximal end, a distalend, a proximal portion, and a distal portion. The occlusion system alsoincludes an occlusion device coupled to the delivery catheter. Theocclusion device is in a reduced profile delivery configuration. Theocclusion device includes a barrier member including a radiallyenlargeable portion, a tail portion extending from the enlargeableportion, an anchor feature arranged with the enlargeable portion of thebarrier member, and a lumen. The lumen extends through the enlargeableportion and the anchor portion and is configured to receive the deliverycatheter. The enlargeable portion and the tail portion are releasablycoupled to the catheter such that the tail portion is radiallyunsupported and collapsible upon deployment from the delivery catheter.

According to another example (“Example 2”) further to Example 1, theanchor feature includes a support member coupled to the enlargeableportion of the barrier member. The support member is expandable from adelivery configuration to a deployed configuration.

According to another example (“Example 3”) further to any one ofExamples 1 to 2, the tail portion of the barrier member is configured tobe released from the delivery catheter upon application of a retractionforce to the tail portion with the catheter.

According to another example (“Example 4”) further to any one ofExamples 1 to 3, the tail portion is configured to plastically deformand neck down in diameter upon application of the retraction force onthe tail portion prior to release of the tail portion from the catheter.

According to another example (“Example 5”) further to any one ofExamples 1 to 4, the tail portion includes opposing, longitudinalcreases configured to facilitate radial collapsing of the tail portionfollowing release from the catheter.

According to another example (“Example 6”) further to any one ofExamples 1 to 5, the tail portion is adhered to the catheter.

According to another example (“Example 7”) further to any one ofExamples 1 to 6, the tail portion is formed of an elastomeric material.The tail portion is configured to constrict following release from thedelivery catheter.

According to another example (“Example 8”) further to any one ofExamples 1 to 7, a ratio of the outer diameter of the barrier member tothe length of the barrier member is at least 1 to 10.

According to another example (“Example 9”) further to any one ofExamples 1 to 8, the tail portion is configured to evert through theenlargeable portion during retraction of the catheter followingdeployment of the enlargeable portion.

According to another example (“Example 10”) further to any one ofExamples 1 to 9, the anchor feature includes at least one of: adhesive,one or more barbs, and an expandable framework.

According to another example (“Example 11”) further to any one ofExamples 1 to 10, the system also includes a balloon. The balloon isconfigured to expand the enlargeable portion from the deliveryconfiguration to the deployed configuration upon inflation of theballoon.

According to another example (“Example 12”) further to any one ofExamples 1 to 11, the system also includes a constraint. The constraintis configured to prevent expansion of the enlargeable portion prior todeployment.

According to another example (“Example 13”), an implantable medicaldevice includes a barrier member. The barrier member includes a firstend, a second end, an enlargeable portion configured to expand from adelivery configuration to a deployed configuration, a tail portion, alumen extending from the first end to the second end, a length, and anouter diameter. The tail portion is configured to flatten against itselfto form a seal. The implantable medical device also includes an anchorfeature coupled to the barrier member at the enlargeable portion. Theanchor feature is configured to expand with the barrier member from thedelivery configuration to the deployed configuration.

According to another example (“Example 14”) further to Example 13, aratio of the outer diameter of the barrier member to the length of thebarrier member is at least 1 to 10.

According to another example (“Example 15”) further to any one ofExamples 13 to 14, the anchor feature includes at least one of:adhesive, one or more barbs, and an expandable framework.

According to another example (Example 16″) further to any one ofExamples 13 to 15, the anchor feature includes a support member. Thesupport member has an expandable framework.

According to another example (“Example 17”) further to any one ofExamples 13 to 16, the first end and the second end of the barriermember are substantially open while the enlargeable portion is in thedelivery configuration.

According to another example (“Example 18”) further to any one ofExamples 13 to 17, the second end of the barrier member is substantiallyclosed while the enlargeable portion is in the deployed configuration.

According to another example (“Example 19”) further to any one ofExamples 13 to 18, the tail portion of the barrier member is configuredto evert upon expansion of the enlargeable portion to the deployedconfiguration.

According to another example (“Example 20”), a method of delivering animplantable medical device includes intraluminally delivering the systemof any one of Examples 1 to 12 to a desired treatment site within a bodylumen of a patient. The method also includes expanding the enlargeableportion of the barrier member to fit the body lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description serve to explain the principles of the disclosure.

FIG. 1A shows a profile of an occlusion system in a deliveryconfiguration, according to some embodiments;

FIG. 1B shows a profile of an occlusion system in a deployedconfiguration, according to some embodiments;

FIGS. 2A-2C show various examples of anchor features, according to someembodiments;

FIGS. 3A-3B show various examples of barrier members, according to someembodiments;

FIG. 4 shows a profile of a self-expanding occlusion system, accordingto some embodiments;

FIG. 5 shows a profile of a balloon-expandable occlusion system having anon-everted tail portion, according to some embodiments;

FIG. 6 shows a profile of a balloon-expandable occlusion system havingan everted tail portion, according to some embodiments;

FIGS. 7A-7D show a method of delivering an occlusion device to a bodylumen of a patient, according to some embodiments;

FIGS. 8A-8D show another method of delivery an implantable occlusiondevice to a body lumen of a patient, according to some embodiments;

FIG. 9 is an example of an occlusion device employed within a body lumenof a patient, according to some embodiments;

FIG. 10 is an example of an occlusion device employed within a bodylumen of a patient, according to some embodiments;

FIG. 11A is an example of an occlusion device employed within a bodylumen of a patient, according to some embodiments;

FIG. 11B is an example of an occlusion device employed within a bodylumen of a patient, according to some embodiments.

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

DETAILED DESCRIPTION

Various aspects of the present disclosure relate to designs forimplantable medical devices for occluding body lumens such asvasculature of a patient. The devices can be configured for partial(e.g., restricted flow), selective (e.g., valved flow), and/or totalocclusion as desired. The term “occlusion,” as used herein, includes thepartial, selective, and total occlusion. In addition, various aspects ofthe present disclosure relate to occlusion systems for occlusivetreatment at a desired treatment location within the body of a patient,such as a body lumen of a patient. For reference, the term “body lumen”should be read to include any passage within the body of a patient thatis capable of occlusion. In some examples, the occlusion system mayinclude a delivery catheter and an occlusion device. The occlusiondevice may be self-expanding, expandable by application of an expansionforce, or combinations thereof.

In certain instances, it may be beneficial to seal the body lumenrapidly and efficiently such as, for example, in large or high-flowvascular channels, to prevent further damage to the area or undesirableeffects to the patient. Occlusion systems, according to the examplesprovided herein, can be advantageous in several respects, including theability to be produced using efficient manufacturing processes andprovide fast, secure, and reliable occlusion by effectuating deviceclosure/sealing in response to the natural body pressure (e.g., bloodpressure) within the body lumen.

In some examples, the occlusion systems discussed herein can also treata wide range of body passages with a single device. In some examples,the occlusion systems permit guidewire access through both ends of theocclusion device without compromising luminal sealing, causing an inflowof bodily fluid, or otherwise interfering with efficacy. In someexamples, the system permits one or more guidewires to remain in placeduring device delivery, after device delivery, and/or during and afterocclusion device removal from the patient's body, reducing and/oreliminating the need for multiple devices and/or procedures.

FIG. 1A shows an occlusion system 10 including a delivery catheter 12,an occlusion device 14, and an optional guidewire 16 in a deliveryconfiguration. The delivery catheter 12 is configured for delivering theocclusion device 14 to a desired location in a body of a patient.Examples of body passages in which the system 10 is employable includearteries, veins, airways, the gastrointestinal tract, the urinary tract,the biliary tract, left atrial appendages, walls of the heart, shunts,and other body passages, whether naturally or artificially formed.

As shown in FIG. 1A, in some embodiments, the delivery catheter 12 has aproximal end 18, a distal end 20, a central longitudinal axis XL, aproximal portion 19 near the proximal end 18, and a distal portion 21near the distal end 20. The delivery catheter 12 has a length suitableto reach a desired treatment location within the body of a patient fordelivery of the device 14 to the desired treatment location. Forexample, the delivery catheter 12 may have a length from about 80 cm toabout 140 cm. However, it should be understood that the deliverycatheter 12 can have any length as desired depending on a variety offactors, including the desired treatment location. Although endoluminaldelivery methods are generally described in association with theocclusion system 10, the occlusion system 10 may also be used inlaparoscopic methods and other surgical methods. The delivery catheter12 can include conventional medical grade materials such as nylon,polyacrylamide, polycarbonate, polyethylene, polyformaldehyde,polymethylacrylate, polypropylene, polytetrafluoroethylene,polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomericorganosilicon polymers, Pebax® polyether block amide, and metals such asstainless steel and nitinol.

As shown in FIG. 1A, the occlusion device 14 includes a barrier member30 that is generally impermeable to fluid flow therethrough. Theocclusion device 14 may also include an attachment element 40 capable ofretaining the barrier member 30 within a body lumen. In someembodiments, the barrier member 30 is oriented along the centrallongitudinal axis XL and includes a length L (FIG. 3A). In variousexamples, the barrier member 30 has a generally cylindricalcross-sectional configuration, having an inner diameter D₁ and an outerdiameter D₂ (FIGS. 7A and 7B) when the occlusion device 14 is in thedelivery configuration. The barrier member 30 may be in the form of atubular sleeve or sheath. In some examples, the barrier member 30 issecured to the delivery catheter 12, such as a body 26 of the deliverycatheter 12.

As discussed above, the attachment element 40 is configured to maintainthe barrier member 30 against an inner wall 60 of the body lumen uponexpansion of the barrier member 30 from the delivery configuration tothe deployed configuration. In some embodiments, the attachment element40 may be an anchor feature 42, as shown in FIG. 1B.

FIG. 1B is an example of the device 14 in an expanded, or deployedconfiguration. As further described, the device 14 is expandable betweenthe delivery configuration and the deployed configuration. For example,the occlusion device 14 may be self-expanding, balloon-expandable, orcombinations thereof. As shown, following deployment, the device 14includes an enlargeable portion 22, otherwise referred to as anengagement portion, having an inner diameter D₁′ and an outer diameterD₂′ (not shown) and a sealing portion, or tail portion 24. As describedin further detail below, the tail portion 24 has a central lumen that isconfigured to self-seal under body pressure. For example, the tailportion 24 is optionally formed of a flexible or compliant material assubsequently discussed and is configured to collapse under back-pressureexternal to the tail portion 24. For example, fluid pressure on theupstream side of the attachment element 40 compresses the tail portion24 into a flat or smashed configuration, sealing the barrier member 30and preventing fluid flow therethrough.

FIGS. 2A-C show various examples of anchor features, according to someembodiments. In some embodiments, the anchor feature 42 a may be, forexample, a support member 44, as shown in FIG. 2A. The support member 44includes a framework that is expandable upon application of a radialexpansion force. For example, the support member 44 may be an expandablestent ring, a self-expanding stent, or a balloon expandable stent, amongother things. In some embodiments, the support member 44 is expandableto a suitable size and/or shape to fit inside the body lumen at thedesired treatment location. For example, the support member 44 may havea deployed diameter approximately equal to the inner diameter of thebody lumen at the desired treatment location. The support member 44 maybe formed of a variety of suitable and biocompatible materials such asvarious metallic and non-metallic materials, including shape-memoryalloys, nitinol, stainless steels, expandable polymers, plastics, andother biocompatible metals.

FIG. 2B shows another embodiment of an anchor feature. The anchorfeature 42 may also be, for example, a barb 42 b. As shown in FIG. 2B,the barb 42 b attaches to the inner wall of the body lumen and securesand/or seals the barrier member 30 at the desired treatment location.For example, the barb 42 b may be any of a spike, spur, hook or otherfeature that catches the inner wall of the body lumen to secure thebarrier member 30 at the desired treatment location.

In another example, shown in FIG. 2C, the anchor feature 42 is anadhesive material 42 c, such as an adhesive strip or coating around anouter wall of the barrier member 30. Upon expansion of the barriermember 30, the adhesive material can adhere to an inner wall of the bodylumen, thereby helping to secure and/or seal the barrier member 30 tothe surrounding body lumen at the desired treatment location. In otherembodiments, the enlargeable portion 22 of the barrier member 30 maysimply comprise a stiffer or more rigid material, as compared to thetail portion 24, such that the enlargeable portion 22 is capable offorming to the inner wall of the body lumen. From the foregoing, itshould be understood that a variety of anchor features 42 arecontemplated, and that a combination of the foregoing examples (e.g.,adhesive, barb, and/or support member combinations) may also beimplemented.

FIGS. 3A-B show various examples of barrier members, according to someembodiments. In some embodiments, the barrier member 30 has a first end32, a second end 34, a first portion 33 near the first end 32, a secondportion 35 near the second end 34, and a lumen 36 extending from thefirst end 32 to the second end 34 along the central longitudinal axisXL. In some embodiments, the barrier member 30 is configured in acontinuous, tubular or cylindrical shape as shown in FIG. 3A. Forexample, the barrier member 30 may be extruded, wrapped, or otherwiseformed as a continuous tube. In some embodiments, the barrier member 30may comprise features to promote collapsing or flattening of the tailportion 24. Such features may include, for example, creases, folds,seams, perforations, and laser cut lines, among other things. In someexamples, the barrier member 30 may comprise one or more layers orsheets of material (e.g., film material) as shown in FIG. 3B. Forexample, the barrier member 30 can include a first sheet 38 adhered to asecond sheet 39 to form a pair of longitudinal seams and a lumen 36. Inother examples, the tail portion 24 of the barrier member 30 may includeopposing, longitudinal creases to facilitate collapsing. As described ingreater detail below, such an arrangement has lower resistance tocollapsing under pressure (e.g., in comparison to a circularcross-section) and may facilitate more effective sealing.

In some examples, the length L of the barrier member 30 may be fromabout 5 cm to about 20 cm. However, the length may vary depending on avariety of factors, including the anatomy of the patient and the desiredtreatment location. The barrier member 30 may have an outer diameter D₂suitable such that a ratio of the outer diameter D₂ to the length L isat least 1 to 10.

In one example, the barrier member 30 is elastomeric and configured tostretch. The barrier member 30 can comprise any suitable, expandable andbiocompatible material. Examples of suitable materials include, forexample, fluoropolymers (e.g., polytetrafluoroethylene), polyurethanes,polyether block amides, and various elastomeric organosilicone polymerssuch as polysiloxanes. In various examples, the barrier member 30comprises a necking film formed of polytetrafluoroethylene,polyethylene, or other materials as desired. As described herein, theterm “necking film” can be defined as a film or layer of materialcapable of deforming longitudinally and decreasing in cross-sectionalarea as a result of localized strain.

FIG. 4 shows a profile of a self-expanding occlusion system, accordingto some embodiments. In some embodiments, the occlusion system 10 mayalso include a constraint 70, otherwise referred to as a sheath or asleeve, configured to prevent the device 14 from self-expanding beforedeployment is desired. As shown, the barrier member 30 may be removablycoupled to the delivery catheter 12 (e.g., the body 26) at a firstportion 33 and/or the first end 32. In some embodiments, at least thefirst portion 33 and/or the first end 32 of the barrier member 30 isexpandable from the delivery configuration to the deployedconfiguration.

FIG. 5 shows a profile of a balloon-expandable occlusion system,according to some embodiments. As shown, the balloon 80 is operablycoupled to the body 26 of the delivery catheter 12 such that the balloon80 is capable of being diametrically adjusted to an enlarged diameter.In some examples, the device 14 is removably coupled to the balloon 80and is configured to expand upon inflation of the balloon 80.

The balloon 80 may be located at any of a variety of locations along thebody 26 of the catheter 12, generally including any point between theproximal end 18 and the distal end 20 of the catheter 12 as desired. Insome embodiments, the barrier member 30 is removably coupled to theballoon 80 at the first portion 33 or the first end 32 of the barriermember 30, as shown in FIG. 5. The barrier member 30 can be coupled tothe balloon 80 at any location along the working length of the balloon80 as desired.

The balloon 80 can comprise a material that is generally inelastic andallows the balloon 80 to expand to a desired diameter upon sufficientpressurization. The balloon 80 can be formed of any of a variety ofsuitable, biocompatible materials. For example, suitable materialsinclude nylon, polyethylene, polyethylene terephthalate (PET),polycaprolactam, polyesters, polyethers, polyamindes, polyurethanes,polyimides, acrylonitrile butadiene styrene (ABS) copolymers,polyester/polyether block copolymers, ionomer resins, liquid crystalpolymers, rigid rod polymers, polyurethanes, latex, and elastomericorganosilicone polymers such as polysiloxanes.

As shown in FIG. 6, in some examples, at least a portion of the barriermember 30 is overlapped onto itself (e.g., during an eversion process).For example, the tail portion 24 of the barrier member 30 is optionallyeverted to define an overlapped portion 25 and an everted length ofmaterial. As shown, both the first end 32 and the second end 34 of thebarrier member 30 are oriented in the same direction (e.g., toward thedistal end 20 of the delivery catheter 12). In some embodiments, theoverlapped portion 25 may be shorter than the tail portion 24. The tailportion 24 may have a length from about 7 cm to about 25 cm or fromabout 10 cm to about 21 cm. However, the tail portion 24 may have anylength as desired, which may depend on the desired treatment location.

In some embodiments, the first end 32 or the tail portion 24 of thebarrier member 30 is optionally coupled or adhered to the body 26 of thedelivery catheter 12 near the distal end 20 of the delivery catheter 12,allowing the first end 32 to be retracted proximally upon removal of thedelivery catheter 12 from the patient's body. In some embodiments, thefirst end 32 or tail portion 24 is adhered to the delivery catheter 12by way of an adhesive material (e.g., an adhesive strip on an inner wallof the lumen 36 of the barrier member 30). However, the first end 32 ortail portion 24 can be coupled to the delivery catheter 12 in a varietyof other ways such as, for example, friction fits, thermal bonding,anchors, fasteners or other types of attachment as desired.

In some embodiments, the first end 32 or tail portion 24 of the barriermember 30 is configured to detach from the delivery catheter 12 byapplication of tension or a retraction force to the catheter followingexpansion of the enlargeable portion 22 of the barrier member 30. Forexample, the tail portion 24 may detach from the delivery catheter 12upon retraction of the delivery catheter 12 from the patient's body. Insome embodiments, the tail portion 24 of the barrier member 30 isconfigured to neck down or reduce in diameter during detachment from thedelivery catheter 12. For example, the tail portion 24 may elasticallyrecover a reduced diameter, or stretch or lengthen during detachmentfrom the delivery catheter 12 to plastically deform to a smallerdiameter, creating a smaller diameter at the first end 32 than at thesecond end 34.

In various examples, the tail portion 24 of the barrier member 30 isradially unsupported and is configured to collapse upon itself underpressure and close. The tail portion 24 may flatten or compress againstitself under external pressure to create a seal. In some embodiments,the barrier member 30 flattens or compresses as a result of the fluidpressure (e.g., blood pressure) within the body lumen. For example, whendeployed, the fluid pressure on a first side of the device 14 andexterior to the barrier member 30, and specifically the tail portion 24of barrier member 30, may be higher than the fluid pressure on a secondside of the device and within the barrier member 30, causing the tailportion 24 of the barrier member 30 to flatten or compress againstitself.

In some embodiments, the tail portion 24 may collapse longitudinally(e.g., by “scrunching”). In some embodiments, the tail portion 24 maycollapse diametrically, such as when tubular (e.g., FIG. 3A). In someembodiments, the barrier member 30 may collapse radially by flattening.For example, when formed with two opposing sides or sheets (e.g., FIG.3B) secured together at opposing seams, the first sheet 39 and secondsheet 41 may readily flatten against one another to close the lumen 36.As discussed above, the barrier member 30 may be creased, scored,pleated, folded, be formed with seams or otherwise treated to encouragerepeatable collapse under pressure.

FIGS. 7A-D show a method of delivering the occlusion device 14 to thedesired treatment area. Although the method discussed herein includes aballoon-expandable system, the method can also be employed forself-expanding systems or other systems.

As shown in FIG. 7A, the occlusion system 10 is introduced into the bodyof a patient and guided along a guidewire 16 to the desired treatmentarea within a body lumen 62. As discussed above, the desired treatmentarea may be any of a vein, artery, gastrointestinal passageway, or otherbody passageway. The body lumen 62 includes an inner wall 60 having aninner diameter D_(L).

Once at the desired treatment location, at least the enlargeable portion22 of the barrier member 30 is expanded from the delivery configuration(FIG. 7A) to the deployed configuration (FIG. 7B). As shown, the barriermember 30 and/or the anchor feature 42 are expanded via inflation of theballoon 80. However, as discussed above, the barrier member 30 and/orthe anchor feature 42 may also be self-expanding upon removal of theconstraint 70 (FIG. 4).

When in the deployed configuration, the barrier member 30 and the anchorfeature 42 have deployed diameters approximately equal to the innerdiameter D_(L) of the body lumen 62. In some embodiments, wherein theanchor feature 42 is a support member 44, the support member 44 createsa pressure fit with the inner wall 60 of the body lumen 62 and maintainsthe barrier member 30 against the inner wall 60. Although shown in usewith the support member 44, the system 10 can use a variety of anchorfeatures 42 as described above. For example, the barrier member 30 canbe maintained or attached to the inner wall 60 via barbs (FIG. 2B)and/or other anchoring mechanisms such as adhesive material (FIG. 2C).

The delivery catheter 12 is then retracted proximally from the bodylumen 62 in the direction denoted by arrow A. In some embodiments, thesecond end 34 is pulled through the enlargeable portion 22 of thebarrier member 30 and forms the tail portion 24 (FIG. 7C) oriented inthe proximal direction. For example, the barrier member 30 is optionallyeverted back through the overlapped portion 25 and the support member 44to form the tail portion 24. In some embodiments, the tail portion 24 isstretched and necked down or reduced in diameter as the deliverycatheter 12 is retracted. In other embodiments, the tail portion 24 mayneck down or reduce in diameter as the support member 44 is expandedfrom the delivery configuration to the deployed configuration. In yetother embodiments, the tail portion 24 flattens or compresses againstitself to form a seal, as discussed above. The second end 34 or tailportion 24 of the barrier member 30 detaches from the delivery catheter12 (e.g., via a shearing action between the deforming tail portion 24and delivery catheter 12) as the delivery catheter 12 is removed fromthe body lumen 62 with the second end 34 of the barrier member 30subsequently closing to form a seal.

As shown in FIG. 7C, the tail portion 24 is oriented in the oppositedirection of fluid flow (denoted by arrow B) through the body lumen 62(i.e., upstream of the support member 44). As discussed above, the fluidpressure on the upstream side of the support member 44 compresses thetail portion 24 into a flat or smashed configuration as indicated inFIG. 7D, sealing the barrier member 30, preventing fluid flowtherethrough and occluding the body lumen 62.

FIGS. 8A-D illustrate another embodiment in which the barrier member 30is not everted as part of assembly to the delivery catheter 12. Asshown, the barrier member 30 is similarly deployed but rather thaneverting the barrier member 30 to form the tail portion 24 viaretraction of the delivery catheter 12, the tail portion 24 is simplypulled, necked down, and released from delivery catheter 12, after whichthe tail portion 24 is compressed by the blood pressure and self-seals.

FIG. 8A shows the occlusion system 10 introduced into the body of apatient and guided along a guidewire 16 to the desired treatment areawithin a body lumen 62. As discussed above, the desired treatment areamay be any of a vein, artery, gastrointestinal passageway, or other bodypassageway.

Once at the desired treatment location, at least the enlargeable portion22 of the barrier member 30 is expanded from the delivery configuration(FIG. 8A) to the deployed configuration (FIG. 8B). As shown, the barriermember 30 and/or the anchor feature 42 are expanded via inflation of theballoon 80. However, as discussed above, the barrier member 30 and/orthe anchor feature 42 may also be self-expanding upon removal of theconstraint 70.

The delivery catheter 12 is then retracted proximally from the bodylumen 62 in the direction denoted by arrow A. In some embodiments, thesecond end 34 remains in the proximal direction (FIG. 8C). The tailportion 24 may then be stretched and necked down or reduced in diameteras the delivery catheter 12 is retracted through the barrier member 30.In other embodiments, the tail portion 24 may neck down or reduce indiameter as the support member 44 is expanded from the deliveryconfiguration to the deployed configuration. In yet other embodiments,the tail portion 24 flattens or compresses against itself to form aseal, as discussed above.

As shown in FIG. 8C, the tail portion 24 is oriented in the oppositedirection of fluid flow (denoted by arrow B) through the body lumen 62(i.e., upstream of the support member 44). As discussed above, the fluidpressure on the upstream side of the support member 44 compresses thetail portion 24 into a flat or smashed configuration as indicated inFIG. 8D, sealing the barrier member 30, preventing fluid flowtherethrough and occluding the body lumen 62.

FIGS. 9-11B show an occlusion device, as describe in detail above,deployed at various desired treatment locations. FIG. 9, for example,shows the occlusion device 14 employed within a body lumen of a patient,according to one embodiment. In such an example, the device 14 is usedto occlude a hole, fenestration, or passageway (e.g., in a Fontanprocedure) between a patient's heart H and inferior vena cava IVC.

In another example, shown in FIG. 10, the device 14 can be used toocclude various passageways in the brain BR to, for example, bypass orocclude an aneurysm AN.

In another example, shown in FIG. 11A, the device 14 can be used as anoptional one-way valve. For example, the device 14 may be placed in aurinary tract UT (downstream of a patient's bladder BL) to mitigateand/or reduce the severity of certain conditions such as, for example,urinary incontinence. If fluid pressure drops on an upstream side of thedevice 14, the tail portion 24 (oriented on the upstream side of thedevice 14) may collapse upon itself and form a seal.

In another example, shown in FIG. 11B, the device 14 can be used as aone-way relief valve for treating conditions such as hydrocephalus, inwhich cerebrospinal fluid builds up in the brain and must beoccasionally relieved. In such examples, the device 14 may allow fluidflow in one direction (i.e., in the case of hydrocephalus, from a brainventricle (BV) into the venous system (V)) if the fluid pressure on theupstream side of the device 14 exceeds the fluid pressure on thedownstream side of the device 14 or the side of the device 14 in whichthe tail portion 24 is oriented. If fluid pressure on the downstreamside of the device 14 exceeds pressure on the upstream side, the tailportion 24 may collapse upon itself and form a seal.

The examples that follow illustrate the performance of various designsconsistent with the foregoing description. These examples should be readin an illustrative manner, and should no be read to limit the scope ofthe disclosure.

EXAMPLES

The following examples illustrate the correlation between everted taillength and amount of leakage for barrier members having varyingdiameters. The barrier members used in all examples had a startinglength of 8 inches. The barrier members were comprised of ePTFE filmcapable of stretching and/or necking down from a starting diameter to asmaller, necked diameter upon eversion. After eversion, the barriermember was then placed inside of a plastic cylinder and the cylinder wasfilled with water to a pressure that simulated blood pressure in thehuman body. The barrier member was cut shorter after each sample run.For example, the barrier member was cut from 8 inches to 6 inches afterthe first sample run. Therefore, the same barrier member was used foreach sample.

Example 1

The effect of everted tail length on leakage was observed for a barriermember having an original diameter of 0.050 inches (0.127 cm). Thevarious water pressures and respective everted tail lengths of eachsample are denoted in Table 1 below.

TABLE 1 Water Pressure Everted Tail Length Sample (in. H₂O) (in.)Observations 1 36 8 No leakage 2 48 6 No leakage 3 48 4 Trace leakage 448 3 Slow leakage 5 48 2 Moderate leakage

As shown in Table 1, Samples 1 and 2 having an everted tail length of 8inches (20.32 cm) and 6 inches (15.24 cm), respectively, exhibited nosigns of visible leakage when subjected to a water pressure similar tothat of blood pressure. Sample 3, having an everted tail length of 4inches (10.16 cm), exhibited trace amounts of leakage. While Samples 4and 5, having everted tail lengths of 3 inches (7.62 cm) and 2 inches(5.08 cm), respectively, exhibited slow to moderate leakage. Therefore,it was concluded that shorter everted tail lengths, specifically taillengths of less than 4 inches (7.62 cm), exhibited a greater amount ofleakage than longer everted tails.

Example 2

The effect of everted tail length on leakage was observed for a barriermember having a diameter of 0.100 inches (0.254 cm). The various waterpressures and respective everted tail lengths of each sample are denotedin Table 2 below.

TABLE 2 Water Pressure Everted Tail Length Sample (in. H₂O) (in.)Observations 6 48 6 Slow leakage 7 48 4 Moderate leakage 8 48 2 Fastleakage

As shown in Table 2, Sample 6 having an everted tail length of 6 inches(15.24 cm) exhibited slower leakage than Samples 7 and 8, having evertedtail lengths of 4 inches (7.62 cm) and 2 inches (5.08 cm), respectively.Therefore, as concluded in Experiment 1, generally, longer everted taillengths correlate to less and/or slower leakage and shorter everted taillengths correlate to more and/or faster leakage.

When comparing Examples 1 and 2, it was concluded that a smallerdiameter tube exhibited less leakage than a larger diameter tube havingthe same everted tail length. For example, Sample 2, having a diameterof 0.050 inches (0.127 cm) and a tail length of 6 inches (15.24 cm),exhibited less leakage than Sample 6, having the same tail length but alarger diameter of 0.100 inches (0.254 cm). Similarly, Examples 3 and 7had the same tail length (4 inches), but Example 3 exhibited only traceamounts of leakage, while Example 7 exhibited moderate leakage.

As disclosed above, Examples 1 and 2 were conducted in a plasticcylinder with water used to simulate blood pressure. Since blood andother bodily fluids are generally more viscous than water, the evertedtail is expected to leak less and/or slower than observed in Examples 1and 2 above. Thus, samples where no leakage or only trace leakage wasobserved would be expected to ultimately occlude during use in the humanbody.

The invention of this application has been described above bothgenerically and with regard to specific embodiments. It will be apparentto those skilled in the art that various modifications and variationscan be made in the embodiments without departing from the scope of thedisclosure. Thus, it is intended that the embodiments cover themodifications and variations of this invention provided they come withinthe scope of the appended claims and their equivalents.

1. An occlusion system comprising: a delivery catheter having a proximalend, a distal end, a proximal portion, and a distal portion; and anocclusion device coupled to the delivery catheter with the occlusiondevice in a reduced profile delivery configuration, the occlusion deviceincluding: a barrier member including a radially enlargeable portion, atail portion extending from the enlargeable portion, an anchor featurearranged with the enlargeable portion of the barrier member, and a lumenextending through the enlargeable portion and the anchor portion andconfigured to receive the delivery catheter, the enlargeable portion andthe tail portion being releasably coupled to the catheter such that thetail portion is radially unsupported and collapsible upon deploymentfrom the delivery catheter.
 2. The system of claim 1, wherein the anchorfeature includes a support member coupled to the enlargeable portion ofthe barrier member, the support member being expandable from a deliveryconfiguration to a deployed configuration.
 3. The system of claim 1,wherein the tail portion of the barrier member is configured to bereleased from the delivery catheter upon application of a retractionforce to the tail portion with the catheter.
 4. The system of claim 1,wherein the tail portion is configured to plastically deform and neckdown in diameter upon application of the retraction force on the tailportion prior to release of the tail portion from the catheter.
 5. Thesystem of claim 1, wherein the tail portion includes opposing,longitudinal creases configured to facilitate radial collapsing of thetail portion following release from the catheter.
 6. The system of claim1, wherein the tail portion is adhered to the catheter.
 7. The system ofclaim 1, wherein the tail portion is formed of an elastomeric materialand is configured to constrict following release from the deliverycatheter.
 8. The system of claim 1, wherein a ratio of the outerdiameter of the barrier member to the length of the barrier member is atleast 1 to
 10. 9. The system of claim 1, wherein the tail portion isconfigured to evert through the enlargeable portion during retraction ofthe catheter following deployment of the enlargeable portion.
 10. Thesystem of claim 1, wherein the anchor feature includes at least one of:adhesive, one or more barbs, and an expandable framework.
 11. The systemof claim 1, further comprising a balloon configured to expand theenlargeable portion from the delivery configuration to the deployedconfiguration upon inflation of the balloon.
 12. The system of claim 1,further comprising a constraint configured to prevent expansion of theenlargeable portion prior to deployment.
 13. An implantable medicaldevice, comprising: a barrier member having a first end, a second end,an enlargeable portion configured to expand from a deliveryconfiguration to a deployed configuration, a tail portion, a lumenextending from the first end to the second end, a length, and an outerdiameter, wherein the tail portion is configured to flatten againstitself to form a seal; and an anchor feature coupled to the barriermember at the enlargeable portion, the anchor feature configured toexpand with the barrier member from the delivery configuration to thedeployed configuration.
 14. The device of claim 13, wherein a ratio ofthe outer diameter of the barrier member to the length of the barriermember is at least 1 to
 10. 15. The device of claim 13, wherein theanchor feature includes at least one of: adhesive, one or more barbs,and an expandable framework.
 16. The device of claim 13, wherein theanchor feature comprises a support member having an expandableframework.
 17. The device of claim 13, wherein the first end and thesecond end of the barrier member are substantially open while theenlargeable portion is in the delivery configuration.
 18. The device ofclaim 13, wherein the second end of the barrier member is substantiallyclosed while the enlargeable portion is in the deployed configuration.19. The device of claim 13, wherein the tail portion of the barriermember is configured to evert upon expansion of the enlargeable portionto the deployed configuration.
 20. A method of delivering an implantablemedical device, the method comprising: intraluminally delivering thesystem of claim 1 to a desired treatment site within a body lumen of apatient; expanding the enlargeable portion of the barrier member to fitthe body lumen; retracting the catheter in a proximal direction suchthat the tail portion of the barrier member everts proximally anddetaches from the delivery catheter, the tail portion of the barriermember flattening against itself and substantially closing to form aseal.